Pharmacologic class: GI agent
Therapeutic class: Anti-inflammatory
Pregnancy risk category B
Metabolized in colon to mesalamine and then to 5-aminosalicylic acid, both of which are thought to exert local anti-inflammatory effect by inhibiting prostaglandin and acid metabolites.
Capsules: 750 mg
Indications and dosages
➣ Mildly to moderately active ulcerative colitis
Adults: Usual dosage, three 750-mg capsules P.O. t.i.d. (6.75 g daily) for up to 8 weeks; some patients may require 12 weeks
Children ages 5 to 17: Usual dosage, either three 750-mg capsules P.O. t.i.d. (6.75 g daily) for up to 8 weeks, or one 750-mg capsule P.O. t.i.d. (2.25 g daily) for up to 8 weeks
• Hypersensitivity to balsalazide, salicylates, or mesalamine
Use cautiously in:
• renal impairment
• pyloric stenosis
• breastfeeding patients
• children younger than age 5 (safety and efficacy not established).
• Advise patient to swallow capsules whole, either always with or always without food.
• For those patients who can't swallow capsules whole, carefully open capsules and sprinkle contents on applesauce and have patient swallow contents immediately without chewing.
CNS: headache, insomnia, dizziness, anxiety, confusion, agitation, coma
EENT: blurred vision, eye irritation, tinnitus, earache, epistaxis, sinusitis, sore throat, nasopharyngitis
GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, anorexia, oral blisters, oral candidiasis,
GU: urinary tract infection
Musculoskeletal: arthralgia; myalgia; bone, back, neck, or limb pain
Respiratory: cough, upper respiratory tract infection
Other: generalized pain
Drug-drug. Oral antibiotics: interference with balsalazide action
• Assess character and frequency of stools.
• Monitor CBC and liver and kidney function test results.
• Instruct patient to take drug only as directed.
• Instruct patient to carefully open capsules and sprinkle contents on applesauce and swallow contents immediately without chewing if patient can't swallow capsules whole.
• Tell patient that teeth and tongue staining may occur when drug is taken by sprinkling on applesauce.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.